FDA Adverse Event
Malfunction
Summary report: N
RUSCH MRI COND FIBER OPTIC LARYN KIT
MDR report key: 3886523
·
Received April 14, 2014
Report
- Report Number
- 1044475-2014-00125
- Event Type
- Malfunction
- Date Received
- April 14, 2014
- Date of Event
- April 2, 2014
- Report Date
- April 2, 2014
- Manufacturer
- TELEFLEX
- Product Code
- OGH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SAMPLE WAS NOT RETURNED FOR EVALUATION AT THE TIME OF THIS REPORT.
Description of Event or Problem · 1
THE COMPLAINT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE DEVICE WILL NOT LIGHT UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 228169 | RUSCH MRI COND FIBER OPTIC LARYN KIT | MRI LARYNGOSCOPE KIT | OGH | TELEFLEX |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |